NeuroSENSE Monitoring System, Model NS-901— 510(k) K202621

Name: FDA 510(k) clearance K202621
Creator: U.S. Food and Drug Administration
Published: 2021-08-05

Substantially Equivalent

Neurowave Systems, Inc.

FDA 510(k) clearance K202621 for NeuroSENSE Monitoring System, Model NS-901, Substantially Equivalent on 2021-08-05. Applicant: Neurowave Systems, Inc.. Device class: 2.

Clearance details

Applicant: Neurowave Systems, Inc.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2020-09-10
Decision date: 2021-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland Heights, OH, US

Download summary PDF View on FDA.gov ↗

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